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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 9070 Introduced in House (IH)]

<DOC>

118th CONGRESS
  2d Session
                                H. R. 9070

To amend title 35, United States Code, to prohibit product hopping, and 
                          for other purposes.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                             July 18, 2024

   Mr. Issa (for himself and Mr. Johnson of Georgia) introduced the 
 following bill; which was referred to the Committee on the Judiciary, 
  and in addition to the Committees on Ways and Means, and Energy and 
Commerce, for a period to be subsequently determined by the Speaker, in 
   each case for consideration of such provisions as fall within the 
                jurisdiction of the committee concerned

_______________________________________________________________________

                                 A BILL

 
To amend title 35, United States Code, to prohibit product hopping, and 
                          for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Affordable Prescriptions for 
Patients Act of 2024''.

SEC. 2. TITLE 35 AMENDMENTS.

    (a) In General.--Section 271(e) of title 35, United States Code, is 
amended--
            (1) in paragraph (2)(C), in the flush text following clause 
        (ii), by adding at the end the following: ``With respect to a 
        submission described in clause (ii), the act of infringement 
        shall extend to any patent that claims the biological product, 
        a method of using the biological product, or a method or 
        product used to manufacture the biological product.''; and
            (2) by adding at the end the following:
    ``(7)(A) Subject to subparagraphs (C), (D), and (E), if the sponsor 
of an approved application for a reference product, as defined in 
section 351(i) of the Public Health Service Act (42 U.S.C. 262(i)) 
(referred to in this paragraph as the `reference product sponsor'), 
brings an action for infringement under this section against an 
applicant for approval of a biological product under section 351(k) of 
such Act that references that reference product (referred to in this 
paragraph as the `subsection (k) applicant'), the reference product 
sponsor may assert in the action a total of not more than 20 patents of 
the type described in subparagraph (B), not more than 10 of which shall 
have issued after the date specified in section 351(l)(7)(A) of such 
Act.
    ``(B) The patents described in this subparagraph are patents that 
satisfy each of the following requirements:
            ``(i) Patents that claim the biological product that is the 
        subject of an application under section 351(k) of the Public 
        Health Service Act (42 U.S.C. 262(k)) (or a use of that 
        product) or a method or product used in the manufacture of such 
        biological product.
            ``(ii) Patents that are included on the list of patents 
        described in paragraph (3)(A) of section 351(l) of the Public 
        Health Service Act (42 U.S.C. 262(l)), including as provided 
        under paragraph (7) of such section 351(l).
            ``(iii) Patents that--
                    ``(I) have an actual filing date of more than 4 
                years after the date on which the reference product is 
                approved; or
                    ``(II) include a claim to a method in a 
                manufacturing process that is not used by the reference 
                product sponsor.
    ``(C) The court in which an action described in subparagraph (A) is 
brought may increase the number of patents limited under that 
subparagraph--
            ``(i) if the request to increase that number is made 
        without undue delay; and
            ``(ii)(I) if the interest of justice so requires; or
            ``(II) for good cause shown, which--
                    ``(aa) shall be established if the subsection (k) 
                applicant fails to provide information required section 
                351(k)(2)(A) of the Public Health Service Act (42 
                U.S.C. 262(k)(2)(A)) that would enable the reference 
                product sponsor to form a reasonable belief with 
                respect to whether a claim of infringement under this 
                section could reasonably be asserted; and
                    ``(bb) may be established--
                            ``(AA) if there is a material change to the 
                        biological product (or process with respect to 
                        the biological product) of the subsection (k) 
                        applicant that is the subject of the 
                        application;
                            ``(BB) if, with respect to a patent on the 
                        supplemental list described in section 
                        351(l)(7)(A) of Public Health Service Act (42 
                        U.S.C. 262(l)(7)(A)), the patent would have 
                        issued before the date specified in such 
                        section 351(l)(7)(A) but for the failure of the 
                        Office to issue the patent or a delay in the 
                        issuance of the patent, as described in 
                        paragraph (1) of section 154(b) and subject to 
                        the limitations under paragraph (2) of such 
                        section 154(b); or
                            ``(CC) for another reason that shows good 
                        cause, as determined appropriate by the court.
    ``(D) In determining whether good cause has been shown for the 
purposes of subparagraph (C)(ii)(II), a court may consider whether the 
reference product sponsor has provided a reasonable description of the 
identity and relevance of any information beyond the subsection (k) 
application that the court believes is necessary to enable the court to 
form a belief with respect to whether a claim of infringement under 
this section could reasonably be asserted.
    ``(E) The limitation imposed under subparagraph (A)--
            ``(i) shall apply only if the subsection (k) applicant 
        completes all actions required under paragraphs (2)(A), 
        (3)(B)(ii), (5), (6)(C)(i), (7), and (8)(A) of section 351(l) 
        of the Public Health Service Act (42 U.S.C. 262(l)); and
            ``(ii) shall not apply with respect to any patent that 
        claims, with respect to a biological product, a method for 
        using that product in therapy, diagnosis, or prophylaxis, such 
        as an indication or method of treatment or other condition of 
        use.''.
    (b) Applicability.--The amendments made by subsection (a) shall 
apply with respect to an application submitted under section 351(k) of 
the Public Health Service Act (42 U.S.C. 262(k)) on or after the date 
of enactment of this Act.
    (c) Medicare Improvement Fund.--Section 1898(b)(1) of the Social 
Security Act (42 U.S.C. 1395iii(b)(1)) is amended by striking ``$0'' 
and inserting ``$1,800,000,000''.
                                 <all>
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